The reduce obesity and diabetes (ROAD) project: Design and methodological considerations

Background: The Reduce Obesity and Diabetes (ROAD) project is a multisite randomized trial to determine the prevalence and progression of risk factors for obesity and its co-morbidities (in particular, type 2 diabetes) and the efficacy of one, two, or three doses of a school-based health, nutrition, and exercise program on these risk factors in a multiethnic population of urban middle school children ages 11-15 years. ROAD is a response to the recent large increases in pediatric obesity and its co-morbidities. Methods: Students enrolled in ROAD undergo evaluation of physical (adiposity and fitness), historical (family history of obesity and diabetes), and biochemical (insulin sensitivity, insulin secretory capacity, lipids, and markers of inflammation) as well as behavioral (self-esteem, dietary and exercise habits, health knowledge) risk factors for adiposity-related co-morbidities. Students are evaluated in the fall and spring of each year and receive either a 3-to 4-mo school-based health, nutrition, and exercise intervention in the period between the testing sessions (experimental group) or after all testing is completed (control group). Results: Between September, 2006, and September, 2010, over 700 students from five different New York City middle schools have been enrolled in ROAD for periods ranging from 1 to 3 years. Conclusions: The detailed data analyses should provide a uniquely broad assessment of the risk factors for co-morbidities related to adiposity and of the efficacy of an easily reproducible intervention on these risk factors. This article describes the rationale, design, and methods of ROAD.